Identity
- Trade Name
- Guide Guiding sleeve, FDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- Guide Guiding sleeve, height 3 mm, Titanium d 5.0 mm FDA UDI
- Model / Reference
- J3734.5003 FDA UDI
- Description
- Guide Guiding sleeve, height 3 mm, Titanium d 5.0 mm FDA UDI
Identifiers
- Catalog Number
- J3734.5003 FDA UDI
- Primary DI / UDI-DI
- E219J373450031 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Surgical drill guide, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Guide Guiding sleeve, by ALTATEC GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (1)
- FDA UDI 6c83aecb-196a-4bec-b6c1-352b8cd5cebd 36 fields · synced May 30, 2026